Skip to main content

Disposables in Downstream Processing

  • Chapter
  • First Online:
Disposable Bioreactors

Part of the book series: Advances in Biochemical Engineering / Biotechnology ((ABE,volume 115))

Abstract

Disposable equipment has been used for many years in the downstream processing industry, but mainly for filtration and buffer/media storage. Over the last decade, there has been increasing interest in the use of disposable concepts for chromatography, replacing steel and glass fixed systems with disposable plastic modules that can be discarded once exhausted, fouled or contaminated. These modules save on cleaning and validation costs, and their reduce footprints reduce buffer consumption, water for injection, labor and facility space, contributing to an overall reduction in expenditure that lowers the cost of goods. This chapter examines the practical and economic benefits of disposable modules in downstream processing.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 299.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 379.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 379.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Abbreviations

BSA:

Bovine serum albumin

cGMP:

Current good manufacturing practice

CIP:

Cleaning in place

DNA:

Deoxyribonucleic acid

LRV:

Log reduction value

MuLV:

Murine leukemia virus

MVM:

Minute virus of mice

PRV:

Pseudorabies Virus

SIP:

Steaming in place

References

  1. Sinclair A, Monge M (2004) BioProcess Int 2:26

    Google Scholar 

  2. Meyeroltmanns F, Schmitz J, Nazlee M (2005) BioProcess Int 3:60

    Google Scholar 

  3. Walter JK (1998) In: Subramanian G (ed.) Bioseparation and bioprocessing. processing, quality and characterization, economics, safety and hygiene. Wiley-VCH, p 447

    Google Scholar 

  4. Ransohoff T (2004) Poster Presentation at BPD North Carolina Biotechnology Center

    Google Scholar 

  5. Gottschalk U (2006) Biopharm Int 19(Suppl):8

    Google Scholar 

  6. Muller-Spath T, Morbidelli M (2009) In: Gottschalk U (ed.) Downstream processing of antibodies. Wiley, New York (in press)

    Google Scholar 

  7. Kelley B (2007) Biotechnology Prog 23:995

    CAS  Google Scholar 

  8. Low D, O’Leary R, Pujar NS (2007) J Chromatogr B 848:48

    Article  CAS  Google Scholar 

  9. European Commission Enterprise Directorate General (2001) Working party on control of medicines and inspections. EU guide to good manufacturing practice, vol. 4, Annex 15, July 2001, Cleaning Validation

    Google Scholar 

  10. FDA (2004) Equipment cleaning and maintenance. Code of Federal Regulations (CFR) Part 211.67 Title 21 Rev. FDA, Rockville MD

    Google Scholar 

  11. FDA (2006) Guide to inspections validation of cleaning processes. FDA, Rockville MD

    Google Scholar 

  12. Gottschalk U (2005) BioPharm Int 18:24

    Google Scholar 

  13. Mora J, Sinclair A, Delmdahl N, Gottschalk U (2006) Bioprocess Int 4(Suppl):38

    CAS  Google Scholar 

  14. CPMP (1996) Note for guidance on virus validation studies. The design, continuation and interpretation of studies validating the inactivation and removal of viruses. CPMP/BWP/268/95

    Google Scholar 

  15. Immelmann A, Kellings K, Stamm O, Tarrach K (2005) Bioprocess Int 3:38

    CAS  Google Scholar 

  16. DiBlasi K, Jornitz MW, Gottschalk U, Priebe PM (2006) The BioPharm Int (suppl) 19:6

    Google Scholar 

  17. Gottschalk U (2008) Biotechnol Prog 24:496

    Article  CAS  Google Scholar 

  18. Prashad M, Tarrach K (2006) FISE 9:28

    Google Scholar 

  19. Tarrach K, Köhler K, Grimm C (2008) Pharma Tech Eur 20:1

    Google Scholar 

  20. Curling J, Gottschalk U (2007) BioPharm Intl 20:70

    CAS  Google Scholar 

  21. Gebauer K, Thommes J, Kula M (1997) Biotechnol Bioeng 54:181

    Article  CAS  Google Scholar 

  22. Gottschalk U, Lamproye A, Zhou J, Sinclair A, Reif O-W (2006) Poster Presentation at Recovery of Biological Products XII

    Google Scholar 

  23. Zhou J (2006) IBC Technology Transfer for Biopharmaceuticals

    Google Scholar 

  24. Sinclair A, Monge M (2002) Pharma Eng 22:20

    Google Scholar 

  25. Lim JAC, Sinclair A, Kim DS, Gottschalk U (2007) BioProcess Intl 5:60

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Uwe Gottschalk .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2009 Springer-Verlag Berlin Heidelberg

About this chapter

Cite this chapter

Gottschalk, U. (2009). Disposables in Downstream Processing. In: Eibl, R., Eibl, D. (eds) Disposable Bioreactors. Advances in Biochemical Engineering / Biotechnology, vol 115. Springer, Berlin, Heidelberg. https://doi.org/10.1007/10_2008_22

Download citation

Publish with us

Policies and ethics